Iclusig blocks the effects of proteins that promote development of cancer cells, the agency said. The drug was granted accelerated approval following a single study of 449 people with either CML or Ph+ ALL.

The product's label will include a boxed warning that users are at heightened risk of blood clots and liver poisoning. More common but less serious clinical side effects included high blood pressure, rash, abdominal pain, fatigue, headache, dry skin, constipation, fever, joint pain, and nausea.

Iclusig is marketed by Ariad Pharmaceuticals, based in Cambridge, Mass.

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